System and method for managing a medical procedure site with a tracking device

ABSTRACT

A system for ensuring the correct location/side of a medical procedure is described. The system includes a pointing device, a receiver, and a validater. The pointing device transmits location data to a receiver from several reference points and a planned medical procedure site on the body of the patient. The validater receives medical procedure plan data associated with the patient and compares the medical procedure plan data with the location data to verify the validity of the planned medical procedure site.

RELATED APPLICATIONS

The present application claims priority from U.S. Provisional PatentApplication Ser. No. 61/230,992 filed Aug. 3, 2009.

TECHNICAL FIELD

Embodiments of the present invention relate to medical devices, and moreparticularly, to a surgical site identification system.

BACKGROUND

Wrong side surgeries are increasing every year despite behavioralrequirements by operative staff and time out procedures. Surgical sitescan be marked by surgeon, patient and surgical nurse and yet mistakesare persistent.

A need exists for a system for ensuring that surgeries are performed onthe correct side of a patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings and in which:

FIG. 1 is a block diagram illustrating one embodiment of a system foridentifying a medical procedure site.

FIG. 2 is a block diagram illustrating one embodiment of a system forverifying a planned medical procedure site.

FIG. 3 is a block diagram illustrating one embodiment of a medicalprocedure site verification computer system.

FIG. 4 is a flow diagram illustrating one embodiment of a method forverifying a planned medical procedure site on a body of a patient.

FIG. 5 is a flow diagram illustrating another embodiment of a method forverifying a planned medical procedure site on a body of a patient.

DETAILED DESCRIPTION

Described herein is a system for verifying a medical procedure site orsurgical location for ensuring medical procedure on a correct side of abody of a patient. The system includes a pointing device, a receiver,and a validater. The pointing device transmits location data to areceiver from several reference points on the body of the patient and aplanned medical procedure site on the body of the patient. The validaterreceives medical procedure plan data associated with the patient andcompares the medical procedure plan data with the location data toverify the validity of the planned medical procedure site.

FIG. 1 is a block diagram illustrating one embodiment of a system forindicating a medical procedure site. Prior to surgery, for example, at adoctor's office, a digital image 102 of a portion of a body of a patientis displayed on a display device 106. The digital image 102 may includefor example, a CT scan, X ray, or other types of digital images.

The physician uses an input device such as a mouse to mark the locationof a surgery site 104 on digital image 102. In one embodiment, thedigital image 102 is oriented according to the body of the patient. Inother words, the left foot is represented as the left foot. Displaydevice 106 communicates with physician's office server 108. Theinformation of the surgery site is stored on physician's office server108 and communicated to operating room server 112 via a computer network(Internet 110). For example, operating room server 112 may located at ahospital where the surgery is to take place. Other pertinent data(patient record) associated with the patient may also be transmitted tooperating room server 112.

FIG. 2 is a block diagram illustrating one embodiment of a system 200for verifying a planned surgery site 230. The body of the patient 218 islaid on an operating table 216. In one embodiment, patient 218 is facedup with his back against the table 216. System 200 includes a handhelddevice 210 such as a pointing device, a receiver 208 such as a pointingdevice reader, an operating room booking sheet 212, and a booking sheetreader 206, an operating room server 204, a digital imaging device 214,and an alarm system 202.

In one embodiment, booking sheet reader 206 includes a bar code scanneror any other type of machine readable marking configured to read data(e.g. a bar code) from operating booking sheet 212 and transmit the datato operating room server 204. Alternatively, data from booking sheet 212may have been already communicated electronically from a physician'soffice or at pre-registration at the hospital to operating room server204. In another embodiment, information about a patient is enteredmanually into operating room server 204.

Booking sheet 212 includes patient information such as a booking number,the name of the patient, date of birth, sex, address, telephone numbers,hospital, surgeon name, date of surgery, nature of surgical procedure,and side of which the surgical procedure is to be performed amongothers. Additional information can include allergies, insuranceinformation, and diagnosis codes, etc. . . .

In one embodiment, a barcode generator is used to generate (not shown) abarcode on booking sheet 212. Barcode generator includes any software orhardware system commonly used to generate barcodes or other machinereadable markings. Booking sheet 212 includes a uniquely generatedbarcode associated with the patient information. Those of ordinaryskills in the art will recognize that other types of machine readablemarking may be used such as Radio Frequency Identification (RFID). Thebarcode may be in the form of a sticker affixed to booking sheet 212.

In one embodiment, booking sheet 212 is generated prior to the surgeryat the hospital. For example, booking sheet 212 may be generated at thetime of registration of the patient.

Digital imaging device 214 includes a display device showing a digitalimage 102 along with the location of the surgery site as marked by thephysician or surgeon in FIG. 1. In one embodiment, operating room server204 verifies that the location of the surgery site 104 from digitalimage 102 corresponds to data from booking sheet 212. Operating roomserver 204 issues a warning notification with alarm system 202 when thelocation of the surgery site 104 from digital image 102 does not matchthe data from booking sheet 212.

In another embodiment, digital imaging device 214 display the digitalimage 102 overlap on another digital image generated by operating roomserver 204. For example, a CT scan of the left foot of the patient maybe overlap with a live outline image of the body of the patient asgenerated by operating room server 204. The outline image may be atwo-dimensional or three-dimensional picture.

In one embodiment handheld device 210 (e.g. infrared pen) wirelesslycommunicates coordinates and location data to receiver 208 (e.g.infrared receiver). The location data from handheld device 210 isrelative to receiver 208. Prior to the surgery on patient 218, a staffor physician uses handheld device 210 to mark the location of severalreference points along the body of patient 218 as instructed by thehandheld device 210 or server 204. For example, system 200 may requestthe staff to point to a reference point 220 on the head of patient 218.Handheld device 210 may include a switch (not shown) on which the staffcan click when the handheld device at the reference point. Location datafrom reference point 220 is then transmitted to receiver 208. In anotherembodiment, upon depressing the switch, receiver 208 reads the locationof handheld device 210 relative to receiver 208.

FIG. 2 illustrates an example of reference points that include, leftshoulder 222, right shoulder 224, right foot 226, and left foot 228among others. In one embodiment, the reference points form an outline ofthe body of patient 218. A minimum number of reference points allows forreceiver 208 or operating room server 204 to determine an orientation ofthe body of patient 218. In other words, receiver 208 and operating roomserver 204 are capable, after receiving the reference points, ofdetermining the left side and right side of patient 218.

After pointing to the reference points, the user/staff is asked to placehandheld device 210 on the planned surgery site 230 and to click theswitch on handheld device 210. Coordinates and location data of theplanned surgery site 230 are then transmitted to receiver 208. Inanother embodiment, upon depressing the switch, receiver 208 reads thelocation of handheld device 210 relative to receiver 208.

As such, receiver 208 and operating room server 204 are then capable ofdetermining whether the planned surgery site 230 is located on the leftor right side of the patient 218 based on the data received fromhandheld device 210.

In another embodiment handheld device 210 (e.g.—a marker) deposits avisual indicator (e.g. ink) on the skin of the patient. Receiver 208(e.g. a camera) can be configured to detect the visual indicator anddetermine the relative position of the visual indicator with respect tothe receiver.

The planned surgery site is the location where the surgeon is planningto operate on. It may or may not be the actual surgery site 104 asprescribed in booking sheet 212. Thus, the term “planned surgery site”is used to distinguish from the “surgery site” as prescribed by thesurgeon in digital image 102 or in booking sheet 212.

The medical procedure is not limited to surgery, but also includes othersurgical and non-surgical medical procedures such as filling a toothcavity at a dentist, removing a tooth, examining an eye or ear, puttinga cast on a limb, acupuncture on a hand, performing a CT scan or X rayon a body part, etc. . . .

FIG. 3 is a block diagram illustrating one embodiment of a surgery siteverification computer system 300 of an operating room server 204.Computer system 300 includes a booking sheet data interface 302, adigital imaging data interface 304, a handheld device interface 306, aprocessing device 320, a storage device 310, and an audio/visualinput/output 326.

Booking sheet data interface 302 enables computer system 300 tocommunicate with booking sheet reader 206. Digital imaging datainterface 304 enables computer system 300 to communicate with digitalimaging device 214. Handheld device interface 306 enables computersystem 300 to communicate with receiver 208. Processing device 320 isconfigured to execute a patient body calibration module 322 and asurgery location validater module 324. Patient body calibration module322 is configured to determine the orientation of the body of thepatient with respect to a fixed pre-determined reference (such asreceiver 208, operating table 216 or the operating room). In otherwords, patient body calibration module 322 is able to determine a leftor right side of the patient 218. Surgery location validater module 324is configured to determine whether the planned surgery site is locatedon the left or right side of patient 218 and to compare the side of theplanned surgery site with the side of the location marked on digitalimage 102 received at digital imaging interface 304. In anotherembodiment, surgery location validater module 324 is configured todetermine whether the planned surgery site is located on the left orright side of the patient and to compare the side of the planned surgerysite with the side of the location prescribed from booking sheet 212 andreceived from booking sheet data interface 302.

Storage device 310 is configured to store booking sheet data 312,digital imaging data 314, calibration data 316, and handheld device data318. Calibration data 316 includes the orientation (where the left andright sides are) of the body of patient 218 as determined by patientbody calibration module 322. Handheld device data 318 includescoordinates/location data received from handheld device 210 or asdetermined by receiver 208.

Audio/visual input/output 326 is configured to issue an audio and/orvisual warning triggered by surgery location validater module 324 whenthe planned surgery site does not corresponding to the surgery siteprescribed in booking sheet 212 and/or as indicated in digital image 102of the portion of the body of patient 218.

In another embodiment, surgery location validater module 324 isconfigured to match the portion of the body of patient 218 with anorientation or outline of the body of patient 218. For example, surgerylocation validater module 324 can determine that a CT scan of a leftfoot indicates that the surgery site is on the left side of the body.

FIG. 3 illustrates a diagrammatic representation of a machine in theexemplary form of a computer system 300 within which a set ofinstructions, for causing the machine to perform any one or more of themethodologies discussed herein, may be executed. In alternativeembodiments, the machine may be connected (e.g., networked) to othermachines in a LAN, an intranet, an extranet, or the Internet. Themachine may operate in the capacity of a server or a client machine inclient-server network environment, or as a peer machine in apeer-to-peer (or distributed) network environment. The machine may be apersonal computer (PC), a tablet PC, a set-top box (STB), a PersonalDigital Assistant (PDA), a cellular telephone, a web appliance, aserver, a network router, switch or bridge, or any machine capable ofexecuting a set of instructions (sequential or otherwise) that specifyactions to be taken by that machine. Further, while only a singlemachine is illustrated, the term “machine” shall also be taken toinclude any collection of machines that individually or jointly executea set (or multiple sets) of instructions to perform any one or more ofthe methodologies discussed herein.

In one embodiment, the exemplary computer system 300 includes processingdevice 320, a main memory (e.g., read-only memory (ROM), flash memory,dynamic random access memory (DRAM) such as synchronous DRAM (SDRAM), astatic memory (e.g., flash memory, static random access memory (SRAM),etc.), and storage device 310, which communicate with each other via abus.

Processing device 320 represents one or more general-purpose processingdevices such as a microprocessor, central processing unit, or the like.More particularly, the processing device may be complex instruction setcomputing (CISC) microprocessor, reduced instruction set computing(RISC) microprocessor, very long instruction word (VLIW) microprocessor,or processor implementing other instruction sets, or processorsimplementing a combination of instruction sets. Processing device 504may also be one or more special-purpose processing devices such as anapplication specific integrated circuit (ASIC), a field programmablegate array (FPGA), a digital signal processor (DSP), network processor,or the like. The processing device 320 is configured to execute modules322, 324 for performing the operations and steps discussed herein with.In one embodiment, modules 322, 324 may be include hardware or softwareor a combination of both.

The computer system 300 may further include a network interface device,a video display unit (e.g., a liquid crystal display (LCD) or a cathoderay tube (CRT)), an alphanumeric input device (e.g., a keyboard), acursor control device (e.g., a mouse), and a signal generation device326 (e.g., a speaker).

Storage device 310 may include a computer-accessible storage medium onwhich is stored one or more sets of instructions (e.g., surgery sitevalidater software 324) embodying any one or more of the methodologiesor functions described herein. The software 324 may also reside,completely or at least partially, within the main memory and/or withinthe processing device 320 during execution thereof by the computersystem 300, the main memory and the processing device 320 alsoconstituting computer-accessible storage media. The software 324 mayfurther be transmitted or received over a network via the networkinterface device.

The computer-accessible storage medium may also be used to store acalibration module 322 and a surgery site validater module 324 aspresently described. Calibration module 322 and surgery site validatermodule 324 may also be stored in other sections of computer system 300,such as static memory.

While the computer-accessible storage medium is shown in an exemplaryembodiment to be a single medium, the term “computer-accessible storagemedium” should be taken to include a single medium or multiple media(e.g., a centralized or distributed database, and/or associated cachesand servers) that store the one or more sets of instructions. The term“computer-accessible storage medium” shall also be taken to include anymedium that is capable of storing, encoding or carrying a set ofinstructions for execution by the machine and that cause the machine toperform any one or more of the methodologies of the present invention.The term “computer-accessible storage medium” shall accordingly be takento include, but not be limited to, solid-state memories, optical andmagnetic media.

FIG. 4 is a flow diagram illustrating one embodiment of a method forverifying a planned surgery site on a body of a patient. The coordinatesand location of several reference points along a perimeter or outline ofthe body of the patient is received at 402. Based on the received data,the orientation of the patient body is determined at 404. In particular,a left side and right side of the patient body is determined. At 406,the system determines the location of the planned surgery site withrespect to the orientation of the body. In particular, the systemdetermines whether the planned surgery site is on the left or right sideof the body of the patient. At 408, the system compares whether the sideof the planned surgery site matches the side of the surgery site asprescribed in a booking sheet of the patient or in a digital imaging ofthe patient. If there is a match, the surgery proceeds at 412. If thedata does not match, the surgery stops at 414.

FIG. 5 is a flow diagram illustrating another embodiment of a method forverifying a planned surgery site on a body of a patient. At 502, adisplay device is used to receive an identification of a surgery site ona patient body. At 504, a system receives coordinate and location dataabout the body of a patient using a handheld device. For example, thesystem receives an outline of the body of the patient at severalpre-determined reference points (right elbow, left shoulder, right hip,etc. . . . ) along a perimeter of the body of the patient.

At 506, the received data is calibrated with respect to a fixedreference such as a receiver or reader of the handheld device. At 508,an outline of the patient body is generated using the received data. At510, the handheld device is also used to transmit coordinate andlocation data from a planned surgery site to the system. At 512, thecoordinate and location data are received from the handheld device. At514, the location data from the handheld device is compared with theoutline of the patient body to determine whether the planned surgerysite is on the right or left side of the body.

At 516, the side of the planned surgery site is compared with the sideof the surgery site as received at 502. If both sides match orcorrespond, the handheld device instructs a user to proceed at 518.Otherwise, the handheld device instructs the user to stop the surgeryprocedure at 520. An audio (alarm) and/or visual message (e.g. redflashing lights or “you must stop. An error condition exists”) may bedisplayed on handheld device or alarm 202, or another output device (notshown).

In the above description, numerous details are set forth. It will beapparent, however, to one skilled in the art, that the present inventionmay be practiced without these specific details. In some instances,well-known structures and devices are shown in block diagram form,rather than in detail, in order to avoid obscuring the presentinvention.

Some portions of the detailed descriptions above are presented in termsof algorithms and symbolic representations of operations on data bitswithin a computer memory. These algorithmic descriptions andrepresentations are the means used by those skilled in the dataprocessing arts to most effectively convey the substance of their workto others skilled in the art. An algorithm is here, and generally,conceived to be a self-consistent sequence of steps leading to a desiredresult. The steps are those requiring physical manipulations of physicalquantities. Usually, though not necessarily, these quantities take theform of electrical or magnetic signals capable of being stored,transferred, combined, compared, and otherwise manipulated. It hasproven convenient at times, principally for reasons of common usage, torefer to these signals as bits, values, elements, symbols, characters,terms, numbers, or the like.

It should be borne in mind, however, that all of these and similar termsare to be associated with the appropriate physical quantities and aremerely convenient labels applied to these quantities. Unlessspecifically stated otherwise as apparent from the following discussion,it is appreciated that throughout the description, discussions utilizingterms such as “processing” or “computing” or “calculating” or“determining” or “reading” or “verifying” or “validating” or the like,refer to the action and processes of a computer system, or similarelectronic computing device, that manipulates and transforms datarepresented as physical (electronic) quantities within the computersystem's registers and memories into other data similarly represented asphysical quantities within the computer system memories or registers orother such information storage, transmission or display devices.

The present invention also relates to apparatus for performing theoperations herein. This apparatus may be specially constructed for therequired purposes, or it may comprise a general purpose computerselectively activated or reconfigured by a computer program stored inthe computer. Such a computer program may be stored in a computerreadable storage medium, such as, but is not limited to, any type ofdisk including floppy disks, optical disks, CD-ROMs, andmagnetic-optical disks, read-only memories (ROMs), random accessmemories (RAMs), EPROMs, EEPROMs, magnetic or optical cards, or any typeof media suitable for storing electronic instructions, and each coupledto a computer system bus.

The algorithms and displays presented herein are not inherently relatedto any particular computer or other apparatus. Various general purposesystems may be used with programs in accordance with the teachingsherein, or it may prove convenient to construct more specializedapparatus to perform the required method steps. The required structurefor a variety of these systems will appear from the description below.In addition, the present invention is not described with reference toany particular programming language. It will be appreciated that avariety of programming languages may be used to implement the teachingsof the invention as described herein.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Many other embodiments will beapparent to those of skill in the art upon reading and understanding theabove description. The scope of the invention should, therefore, bedetermined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

1. A system comprising: a receiver configured to determine, locationdata of a plurality of reference points on a body of a patient and of aplanned medical procedure site on the body of the patient with ahandheld device; and a validater coupled to the receiver, the validaterconfigured to receive medical procedure plan data associated with thepatient and to compare the medical procedure plan data with the locationdata to verify the validity of the planned medical procedure site. 2.The system of claim 1 wherein the location data includes coordinatesdata relative to the receiver.
 3. The system of claim 1 wherein thevalidater comprises: a calibration module configured to determine anorientation of the body of the patient based on the location data of theplurality of reference points on the body of the patient.
 4. The systemof claim 3 wherein the validater comprises: a medical procedure sitevalidater configured to determine a side of the planned medicalprocedure site with respect to the orientation of the body of thepatient, and to compare the side of the planned medical procedure sitewith the medical procedure plan data.
 5. The system of claim 4 furthercomprising: an audio or visual warning device coupled to the surgicalsite validater, the audio or visual warning device configured to issuean audio or visual warning when the side of the planned medicalprocedure site and the side of the body of the patient as prescribed inthe medical procedure plan data do not match.
 6. The system of claim 1wherein the surgical plan data associated with the patient includes datafrom a booking sheet, the booking sheet comprising an identification ofthe patient, a location of the medical procedure site on the body of thepatient, a side of the body on which the medical procedure site islocated, and a surgical procedure for the patient.
 7. The system ofclaim 1 wherein the handheld device includes an infrared pen, whereinthe receiver includes an infrared receiver configured to detect alocation of the handheld device relative to the receiver.
 8. The systemof claim 1 wherein the handheld device includes a marker to deposit anvisual indicator on the skin of the patient at the plurality ofreference points and at the planned medical procedure site, wherein thereceiver is configured to detect the visual indicators and determinetheir relative positions.
 9. The system of claim 1 further comprising: adisplay device configured to display a digital image of at least aportion of the body of the patient; an input device coupled to thedisplay device, the input device configured to identify a medicalprocedure site on the display device; and a server coupled to the inputdevice, the server configured to receive the medical procedure site andthe side of the medical procedure site with respect to the digitalimage.
 10. The system of claim 9 wherein the server is configured togenerate the medical procedure plan data.
 11. A method for managing asurgical site on a patient comprising: receiving surgical plan dataassociated with the patient; determining location data of a plurality ofreference points on a body of a patient and of a planned medicalprocedure site on the body of the patient with a handheld device, thelocation data relative to a receiver; determining an orientation of thebody of the patient based on the location data of the plurality ofreference points, and a side of the planned medical procedure site onthe body of the patient relative to the orientation of the body of thepatient; and comparing the medical procedure plan data with the side ofthe planned medical procedure site to verify the validity of the plannedmedical procedure site.
 12. The method of claim 11 comprising: issuingan audio or visual warning when the side of the planned medicalprocedure site and the side of the body of the patient as prescribed inthe medical procedure plan data do not match.
 13. The method of claim 11wherein the surgical plan data associated with the patient includes datafrom a booking sheet, the booking sheet comprising an identification ofthe patient, a location of the medical procedure site on the body of thepatient, a side of the body on which the medical procedure site islocated, and a surgical procedure for the patient.
 14. The method ofclaim 11 wherein the handheld device includes an infrared pen, whereinthe receiver includes an infrared receiver configured to detect thelocation of the handheld device relative to the receiver.
 15. The methodof claim 11 wherein the handheld device includes a marker to deposit avisual indicator on the skin of the patient at the plurality ofreference points and at the planned medical procedure site, wherein thereceiver is configured to detect the visual indicators and determinetheir relative positions.
 16. The method of claim 11 further comprising:displaying on a display device a digital image of at least a portion ofthe body of the patient; identifying a medical procedure site on thedisplay device with an input device coupled to the display device;determining a side of the medical procedure site with respect to thedigital image; and generating the medical procedure data plan based onthe side of the medical procedure site.
 17. A computer-readable storagemedium, having instructions stored therein, which when executed, cause acomputer system to perform a method comprising: receiving surgical plandata associated with the patient; determining location data of aplurality of reference points on a body of a patient and of a plannedmedical procedure site on the body of the patient with a pointingdevice, the location data relative to a receiver; determining anorientation of the body of the patient based on the location data of theplurality of reference points, and a side of the planned medicalprocedure site on the body of the patient relative to the orientation ofthe body of the patient; and comparing the medical procedure plan datawith the side of the planned medical procedure site to verify thevalidity of the planned medical procedure site.
 18. Thecomputer-readable storage medium of claim 17 wherein the method furthercomprises: issuing an audio or visual warning when the side of theplanned medical procedure site and the side of the body of the patientas prescribed in the medical procedure plan data do not match.
 19. Thecomputer-readable storage medium of claim 17 wherein the surgical plandata associated with the patient includes data from a booking sheet, thebooking sheet comprising an identification of the patient, a location ofthe medical procedure site on the body of the patient, a side of thebody on which the medical procedure site is located, and a surgicalprocedure for the patient.
 20. The computer-readable storage medium ofclaim 17 wherein the handheld device includes an infrared pen, whereinthe receiver includes an infrared receiver configured to detect thelocation of the handheld device relative to the receiver.
 21. Thecomputer-readable storage medium of claim 17 wherein the handheld deviceincludes a marker to deposit a visual indicator on the skin of thepatient at the plurality of reference points and at the planned medicalprocedure site, wherein the receiver is configured to detect the visualindicators and determine their relative positions.
 22. Thecomputer-readable storage medium of claim 17 further comprising:displaying on a display device a digital image of at least a portion ofthe body of the patient; identifying a medical procedure site on thedisplay device with an input device coupled to the display device;determining a side of the medical procedure site with respect to thedigital image; and generating the medical procedure data plan based onthe side of the medical procedure site.